CN102471312B discloses a small molecule compound of (R,E)-N-(4-(3-chloro-4-(pyridin-2-ylmethoxy)phenylamino)-3-cyano-7-ethoxyquinolin-6-yl)-3-(1-methylpyrrolidin-2-yl)-propeneamide that has a structure shown as formula I.

It is known as a small molecule receptor tyrosine kinase inhibitor that inhibits epidermal growth factor receptor (EGFR) and human epidermal factor receptor 2 (ERBB2). It can covalently bind to the ATP binding sites of the kinase domains of EGFR and ERBB2 in cells, prevent the formation of homogeneous and heterogeneous dimers of EGFR and ERBB2 in tumor cells, inhibit their own phosphorylation, and block the activation of downstream signaling pathway, thereby inhibiting the growth of tumor cells. It can be clinically used for the treatment of various tumors such as gastric cancer, lung cancer, and breast cancer, etc.
CN102933574B discloses a maleate salt form of the compound of formula I that has advantages in terms of solubility, bioavailability and pharmacokinetics in comparison to other salts and the compound of formula I itself.
CN103974949B discloses crystal form I of dimaleate salt of the compound of formula I. This crystal form has good crystalline stability and chemical stability, and can be used in the preparation of a medicament for treating diseases associated with EGFR receptor tyrosine kinase or HER-2 receptor tyrosine kinase.
However, when (R,E)-N-(4-(3-chloro-4-(pyridin-2-ylmethoxy)phenylamino)-3-cyano-7-ethoxyquinolin-6-yl)-3-(1-methylpyrrolidin-2-yl)-propeneamide or a pharmaceutically acceptable salt thereof is prepared into a pharmaceutical solid composition, a high viscosity will be formed locally once the active ingredient is dissolved in water. It is not conducive to the preparation of the pharmaceutical formulation, and also causes the decline in drug dissolution rate and nonuniform dissolution rates of the pharmaceutical formulation in different individuals.